Psoriasis VulgarisNCT06064084
Incretin Effect in Patients With Psoriasis and Controls
An observational study of Psoriasis Vulgaris, run by University Hospital, Gentofte, Copenhagen.
Trial summary
To investigate the incretin effect and postprandial incretin responses in plasma in patients with psoriasis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Oral glucose tolerance test, Intravenous isoglycaemic glucose clamp and Liquid Mixed meal test
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 11 Sep 2011to 11 Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Cases with psoriasis vulgaris (PASI>8) Controls with no existing skin disease. Matched for Age, BMI and Sex
Who may be able to join
- no diabetes BMI < 27 kg/m^2 normal Glucose tolerance test at screening normal fasting plasma glucose no islet auto antibodies no hormonel contraception informed consent psoriasis vulgaris (PASI>8) (case not controls)
Who cannot join
- other chronic inflammtory skin disease other chronic inflammatory disease pregnancy psychiatric illness
About this study
Official title: Incretin Effect in Patients With Psoriasis
To investigate the incretin effect and postprandial incretin responses in plasma in patients with psoriasis
- Conditions
- Psoriasis Vulgaris
- Being tested
- Oral glucose tolerance test, Intravenous isoglycaemic glucose clamp, Liquid Mixed meal test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral glucose tolerance testDiagnostic test
Oral glucose tolerance test 50g
Intravenous isoglycaemic glucose clampOther
Intravenous isoglycaemic glucose clamp
Liquid Mixed meal testOther
Liquid Mixed meal test 520 kcal
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis | Not described Receives: Diagnostic Test: Oral glucose tolerance test; Other: Intravenous isoglycaemic glucose clamp; Other: Liquid Mixed meal test | |
| Control | Age, Sex and BMI matched Receives: Diagnostic Test: Oral glucose tolerance test; Other: Intravenous isoglycaemic glucose clamp; Other: Liquid Mixed meal test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incretin effect measured with Beta-cell secretory response
Incretineffect (%) = 100 % × (Beta-cell Secretory Response (OGTT) - Beta-cell Secretory Response (IIGI)) / Beta-cell Secretory Response (OGTT)
Measured: 0-180 minutes
Secondary outcomes (5)
Insulin sensitivity measures
Matsudas insulin sensitivity index: (10,000 / √glucose minute 0 x insulin minute 0) (mean glucose (OGTT) x mean insulin OGTT))
Measured: 0-180 minutes
Concentration of Glucose-independent insulinotropic polypeptide
Evaluted as Area Under the Curve
Measured: 0-180 minutes
Concentration of Glucagon-like peptide 1
Evaluated as Area Under the Curve
Measured: 0-180 minuntes
Concentration of Glucagon
Evaluated as Area Under the Curve
Measured: 0-180 minutes
Concentration of Insulin
Evaluated as Area Under the Curve
Measured: 0-180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start11 Sep 2011
- Primary completion11 Sep 2015
- Study completion11 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filip Krag Knop, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064084
- Sponsor's protocol ID
- 11031999
- Status last verified
- Sep 2023
- First submitted
- 14 Sep 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lauritsen JV, Bergmann N, Junker AE, Gyldenlove M, Skov L, Gluud LL, Hartmann B, Holst JJ, Vilsboll T, Knop FK. Oral glucose has little or no effect on appetite and satiety sensations despite a significant gastrointestinal response. Eur J Endocrinol. 2023 Dec 6;189(6):619-626. doi: 10.1093/ejendo/lvad161.
PubMed 38035766
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incretin Effect in Patients With Psoriasis
- ClinicalTrials.gov ID
- NCT06064084
- Acronym / sponsor ID
- 11031999
- Conditions
- Psoriasis Vulgaris
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- 11 Sep 2011 (actual)
- Primary completion
- 11 Sep 2015 (actual)
- Study completion
- 11 Sep 2015 (actual)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the incretin effect and postprandial incretin responses in plasma in patients with psoriasis
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psoriasis | – | Diagnostic Test: Oral glucose tolerance test, Other: Intravenous isoglycaemic glucose clamp, Other: Liquid Mixed meal test |
| Control | – | Diagnostic Test: Oral glucose tolerance test, Other: Intravenous isoglycaemic glucose clamp, Other: Liquid Mixed meal testAge, Sex and BMI matched |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Cases with psoriasis vulgaris (PASI>8) Controls with no existing skin disease. Matched for Age, BMI and Sex
Key inclusion criteria (1 listed)
- no diabetes BMI < 27 kg/m^2 normal Glucose tolerance test at screening normal fasting plasma glucose no islet auto antibodies no hormonel contraception informed consent psoriasis vulgaris (PASI>8) (case not controls)
Key exclusion criteria (1 listed)
- other chronic inflammtory skin disease other chronic inflammatory disease pregnancy psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral glucose tolerance testOral glucose tolerance test 50g | Diagnostic test | Control, Psoriasis |
| Intravenous isoglycaemic glucose clampIntravenous isoglycaemic glucose clamp | Other | Control, Psoriasis |
| Liquid Mixed meal testLiquid Mixed meal test 520 kcal | Other | Control, Psoriasis |
Primary outcome
Incretin effect measured with Beta-cell secretory response
Time frame: 0-180 minutes
Incretineffect (%) = 100 % × (Beta-cell Secretory Response (OGTT) - Beta-cell Secretory Response (IIGI)) / Beta-cell Secretory Response (OGTT)
5 secondary outcomes
Insulin sensitivity measures
Time frame: 0-180 minutes
Concentration of Glucose-independent insulinotropic polypeptide
Time frame: 0-180 minutes
Concentration of Glucagon-like peptide 1
Time frame: 0-180 minuntes
Concentration of Glucagon
Time frame: 0-180 minutes
Concentration of Insulin
Time frame: 0-180 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Derived from this study: PubMed 38035766Lauritsen JV, Bergmann N, Junker AE, Gyldenlove M, Skov L, Gluud LL, Hartmann B, Holst JJ, Vilsboll T, Knop FK. Oral glucose has little or no effect on appetite and satiety sensations despite a significant gastrointestinal response. Eur J Endocrinol. 2023 Dec 6;189(6):619-626. doi: 10.1093/ejendo/lvad161.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis Vulgaris, run by University Hospital, Gentofte, Copenhagen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incretin effect measured with Beta-cell secretory response (time frame: 0-180 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06064084, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.